Kampf G, Kapella M
Bode Chemie GmbH & Co., Scientific Affairs, Hamburg, Germany.
J Hosp Infect. 2003 Jul;54(3):222-5. doi: 10.1016/s0195-6701(03)00087-2.
In some countries, alcohol-based hand gels are used for hygienic hand disinfection but their efficacy and suitability for surgical hand disinfection has never been investigated. The efficacy of Sterillium Gel was investigated according to prEN 12791 in two separate experiments. Finger tips of 20 volunteers per experiment were sampled for resident skin bacteria before surgical hand disinfection. In a cross-over design, each volunteer carried out a surgical hand disinfection with the reference alcohol [n-propanol 60%, (v/v)] or Sterillium Gel [ethanol 85% (v/v)] for 3 min. After the product application, one hand was sampled for the immediate effect, the other hand was gloved for 3 h and then sampled for the sustained effect. Samples were analysed for remaining resident bacteria. The mean of the pre-value, the 0 h and 3 h values of the reference disinfection and the test product were calculated. With the reference alcohol, respective mean immediate log10-reduction factors of 2.06+/-0.76 and 2.23+/-1.13 were found in both experiments. The mean sustained effects with the reference alcohol were 2.03+/-1.14 and 1.44+/-0.81. Sterillium Gel achieved respective mean immediate effects of 2.48+/-1.06 and 2.13+/-0.81, the mean sustained effects were 2.77+/-0.95 and 2.18+/-0.72. They proved significantly larger than those obtained with the reference alcohol (P<0.05; pair-wise Wilcoxon test). Sterillium Gel, therefore, more than fulfils the efficacy requirements for surgical hand disinfection of prEN 12791. In addition, 25 of 26 operating theatre healthcare workers in an orthopaedic hospital found it suitable for surgical hand disinfection after a single use, which included putting on a pair of surgical gloves. Although none of them had ever used an alcohol-based gel before, they had rather been accustomed to alcohol-based liquid products for years. The main reasons given for the positive assessment were better skin feeling after use, smell and easier donning of the surgical gloves. No significant correlation was found between overall or dermal acceptance and years of professional experience, profession or number of gel portions used for surgical hand disinfection (Pearson's correlation; P>0.05).
在一些国家，酒精基手部凝胶用于手部卫生消毒，但它们对于外科手术手部消毒的有效性和适用性从未得到研究。根据prEN 12791在两项独立实验中对Sterillium凝胶的有效性进行了研究。每次实验选取20名志愿者，在外科手术手部消毒前对其指尖进行常驻皮肤细菌采样。采用交叉设计，每位志愿者分别使用参考酒精（正丙醇60%，体积/体积）或Sterillium凝胶（乙醇85%，体积/体积）进行3分钟的外科手术手部消毒。产品涂抹后，一只手采样以观察即时效果，另一只手戴手套3小时后采样以观察持续效果。对样本进行剩余常驻细菌分析。计算参考消毒和测试产品的预值、0小时和3小时值的平均值。使用参考酒精时，在两项实验中分别发现即时对数10减少因子平均值为2.06±0.76和2.23±1.13。使用参考酒精的持续效果平均值分别为2.03±1.14和1.44±0.81。Sterillium凝胶的即时效果平均值分别为2.48±1.06和2.13±0.81，持续效果平均值分别为2.77±0.95和2.18±0.72。结果证明，这些值显著大于使用参考酒精所获得的值（P<0.05；配对Wilcoxon检验）。因此，Sterillium凝胶完全满足prEN 12791对外科手术手部消毒的有效性要求。此外，一家骨科医院的26名手术室医护人员中有25人认为它单次使用后适用于外科手术手部消毒，这包括戴上一副手术手套。尽管他们中没有人以前使用过酒精基凝胶，但多年来他们一直习惯使用酒精基液体产品。给出积极评价的主要原因是使用后皮肤感觉更好、气味以及戴手术手套更容易。在总体或皮肤接受度与专业经验年限、职业或用于外科手术手部消毒的凝胶份数之间未发现显著相关性（Pearson相关性；P>0.05）。
